BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMAX

    MDR report key: 1709962 · Received May 27, 2010

    Report

    Report Number
    9611253-2010-00011
    Event Type
    Injury
    Date Received
    May 27, 2010
    Report Date
    October 1, 2008
    Manufacturer
    NSK
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS SHOWED NO PROBLEMS WITH MATERIALS, MFR, OR TEST OF SUBJECT DEVICE. RETURNED DEVICE WAS DISASSEMBLED AND EXAMINED. RUST WAS OBSERVED IN BEARING ASSEMBLY, CAUSING OVERHEATING AND INDICATING IMPROPER USER MAINTENANCE (CLEANING/LUBRICATION). DEVICE WAS REPAIRED TO ORIGINAL MFG SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING CONVERSATION, DENTIST REPORTED HANDPIECE BURNED A PT. DENTAL OFFICE CONTACTED ON 11/10/2008, 11/25/2008, 12/16/2008, 02/17/2009, 03/26/2009 AND 03/26/2009 TO OBTAIN ADDITIONAL INFO REGARDING DETAILS OF INCIDENT, BUT NONE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMAX EGS NSK TI95L

    Patients

    Seq Age Sex Outcome Treatment
    1